# US 8,541,372 B2 · Isolated extracellular matrix material including subserous fascia

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- Number: US 8,541,372 B2
- Document ID: US8541372B2
- Status: Granted
- Kind: B2
- Application number: 12/983,350
- Filed: 2011-01-03
- Published: 2011-06-23
- Granted: 2013-09-24
- Earliest claimed: 2008-07-01
- Assignees: Cook Biotech Incorporated
- Applicants: Bhavin Shah; Katie L. Harrigan
- Inventors: Bhavin Shah; Katie L. Harrigan
- Web page: https://patentgrep.com/patent/US8541372B2

## CPC

- A61K 38/39: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- A61L 27/3633: {Extracellular matrix [ECM]}
- A61L 27/3695: {characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this (A61L27/3687, A61L27/3691 take precedence)}
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 2430/40: Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Described are purified extracellular matrix materials isolated from the abdominal wall of animals and including the subserous fascia layer of the abdominal wall. Such medical materials can find use in treating damaged tissue and in certain aspects in providing tissue support for the repair of hernias. Related methods of manufacture and use are also described.

## Claims

### Claim 1

A bioresorbable collagenous and elastinous extracellular matrix graft material having high elasticity and strength, comprising an isolated, bioresorbable layer of highly extensible extracellular matrix material isolated from the abdominal wall of a porcine animal, said extracellular matrix material comprising collagen and elastin and comprising at least the subserous fascia from the abdominal wall, wherein the extracellular matrix material is essentially devoid of native cells, wherein the extracellular matrix material has a tensile strength at break of at least one pound and an elongation at break of at least about 50%, and wherein the extracellular matrix material has a lipid content of less than 15 percent by weight.

### Claim 2 (depends on 1)

The graft material of claim 1, wherein said extracellular matrix material has a lipid content of less than 10 percent by weight.

### Claim 3 (depends on 1)

The graft material of claim 1, wherein said layer also includes parietal peritoneum from the abdominal wall.

### Claim 4 (depends on 1)

The graft material of claim 1, wherein said material is disinfected with an oxidizing disinfectant.

### Claim 5 (depends on 4)

The graft material of claim 4, wherein said oxidizing disinfectant comprises a peroxy compound.

### Claim 6 (depends on 5)

The graft material of claim 5, wherein said peroxy compound is a peracid.

### Claim 7 (depends on 6)

The graft material of claim 6, wherein said peroxy compound is peracetic acid.

### Claim 8 (depends on 1)

The graft material of claim 1, wherein said layer has a length of at least 20 cm and a width of at least 20 cm.

### Claim 9 (depends on 1)

The graft material of claim 1 wherein said extracellular matrix material has a lipid content of less than 5 percent by weight.

### Claim 10 (depends on 1)

The graft material of claim 1, comprising at least two said layers bonded to one another.

### Claim 11 (depends on 10)

The graft material of claim 10, also comprising perforations that allow passage of fluid through the graft material.

### Claim 12 (depends on 10)

The graft material of claim 10, wherein said layers are dehydrothermally bonded to one another.

### Claim 13 (depends on 1)

The graft material of claim 1, in a dehydrated form and sealed in sterile condition within a package.

### Claim 14

A bioresorbable collagenous and elastinous extracellular matrix graft material having high elasticity and strength, comprising an isolated, bioresorbable layer of highly extensible extracellular matrix material isolated from the abdominal wall of a porcine animal, said extracellular matrix material comprising collagen and elastin and comprising at least the subserous fascia from the abdominal wall, wherein the extracellular matrix material is essentially devoid of native cells, wherein the extracellular matrix material has a tensile strength at break of at least one pound and an elongation at break of at least about 50%, and wherein the extracellular matrix material is free from FGF-2.

### Claim 15 (depends on 14)

The graft material of claim 14 wherein said extracellular matrix material comprises hyaluronic acid.

### Claim 16 (depends on 14)

The graft material of claim 14 wherein said extracellular matrix material has a lipid content of less than 15 percent by weight.

### Claim 17 (depends on 14)

The graft material of claim 14, comprising at least two said layers bonded to one another.

### Claim 18

A bioresorbable collagenous and elastinous extracellular matrix graft material having high elasticity and strength, comprising two or more isolated, bioresorbable layers of highly extensible extracellular matrix material isolated from the abdominal wall of a porcine animal, wherein said layers are bonded to one another, said extracellular matrix material comprising collagen and elastin and comprising at least the subserous fascia from the abdominal wall, wherein the extracellular matrix material is essentially devoid of native cells, and wherein the extracellular matrix material has a tensile strength at break of at least one pound and an elongation at break of at least about 50%.

### Claim 19 (depends on 18)

The graft material of claim 18 wherein said extracellular matrix material has a lipid content of less than 15 percent by weight.

### Claim 20 (depends on 18)

The graft material of claim 18 wherein said extracellular matrix material has a lipid content of less than 10 percent by weight.

### Claim 21 (depends on 18)

The graft material of claim 18, also comprising perforations that allow passage of fluid through the graft material.

### Claim 22 (depends on 18)

The graft material of claim 18, wherein said layers are dehydrothermally bonded to one another.

### Claim 23 (depends on 18)

The graft material of claim 18, wherein said layers also include parietal peritoneum from the abdominal wall.

### Claim 24 (depends on 18)

The graft material of claim 18, in a dehydrated form and sealed in sterile condition within a package.

### Claim 25 (depends on 18)

The graft material of claim 18, wherein said layers have a length of at least 20 cm and a width of at least 20 cm.